Customs and Border Protection, Life Sciences

FDA Proposes Submission Tracking Number Requirement for ENDS Imports

Troutman Pepper on 9/17/2024

In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more

There Is Never a Bad Time To Audit Your Supply Chain

Arnall Golden Gregory LLP on 2/1/2022

In late December 2021, the United States banned imports of disposable gloves produced in Malaysia by manufacturer Brightway Holdings over allegations of forced labor....more

Important Clarifications in the Federal Circuit Acetris Decision

Morgan Lewis on 2/21/2020

In addition to standing behind the plain language of the definition of a “US-made end product,” the court in Acetris Health, LLC v. United States provided new guidance regarding limits on Customs and Border Protection...more

Despite Amarin, ITC May Be Right Prescription For Pharma

Pillsbury Winthrop Shaw Pittman LLP on 6/7/2019

Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more

Medical Products & FDA: What to Watch for in 2019

Mintz - Health Care Viewpoints on 12/5/2018

Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues between user fee cycles. FDA regulates 20¢ of every U.S. consumer dollar...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

Arnall Golden Gregory LLP on 10/28/2015

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more